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Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation

NCT06649201 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-03-09

No results posted yet for this study

Summary

The goal of this observational study is to investigate the development of vulvovaginal graft-versus-host- disease (GVHD), an under-reported and under-recognized manifestation of chronic GVHD. This study aims to characterize the vaginal microbiome in participants undergoing allogeneic hematopoietic cell transplantation (HCT). The main questions it aims to answer are:

* Is the vaginal microbiome altered during allogeneic HCT?
* What changes may help researchers understand the development of vulvovaginal GVHD?

Participants will be asked to undergo an assessment of vulvovaginal symptoms through a vulvovaginal symptom questionnaire once pre-transplant, 6 months post-transplant, and twelve12 months post- transplant. Participants will also be asked to undergo a vaginal microbiome (collection of bacteria, fungi, and viruses that live on our bodies) evaluation through a vaginal exam performed by a gynecologist with collection of vaginal samples once pre-transplant and again six months post-treatment and twelve months post-transplant. If a participant develops symptoms of vulvovaginal GVHD at any point in time during the post-transplant follow up, the participant may partake in additional vaginal exams to diagnose GVHD at the time of symptom onset.

Conditions

  • Graft Vs Host Disease
  • Vulvovaginal Signs and Symptoms

Interventions

OTHER

Vulvovaginal Symptom Questionnaire

Participants will undergo assessment of vulvovaginal symptoms via the vulvovaginal questionnaire once pre-transplant, six months, and develop months post-transplant.

DIAGNOSTIC_TEST

Vaginal Microbiome Evaluation

A vaginal microbiome evaluation will be performed via vaginal exam by a gynecologist with collection of vaginal samples once pre-transplant, six months, and twelve months post-transplant.

Sponsors & Collaborators

Principal Investigators

  • Betty K Hamilton, MD · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2026-08-31
Completion
2027-02-15

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06649201 on ClinicalTrials.gov